Status:
COMPLETED
Antipsychotic Therapy and First Episode
Lead Sponsor:
The University of Hong Kong
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
For schizophrenic patients who remained in remission while on maintenance medication, there may come a point in time when the relative risk for relapse become so low that discontinuation of therapy ca...
Eligibility Criteria
Inclusion
- Male or female patients, from 18 to 65 years of age at Visit 1
- Patients must achieve a level of understanding and expressive capacity sufficient to communicate adequately with the study coordinator and to participate in cognitive testing.
- Patients must agree to cooperate with all tests and examinations required by the protocol. They must be willing to comply fully with treatment
- Patient must understand the nature of the study and must sign an informed consent document.
- Patients must be Cantonese speaking Han Chinese
- Patients must be diagnosed, according to the SCID for DSM-IV, with schizophrenia, schizoaffective disorder or schizophreniform psychosis.
- Patients must have good response to anti-psychotic treatment by achieving a rating of 2 or below in Clinical Global Impression Scale (CGI) Severity of illness; a rating of 4 or below in Improvement scale, and a rating of 3 or below in (conceptual disorganization, unusual thought content), a rating of 2 or below in (delusion, hallucinatory behavior) and a rating of 4 or below in (Suspiciousness) of Positive and Negative Syndrome Scale (PANSS) for at least 8 weeks
Exclusion
- Female patients who are either pregnant or lactating.
- Patients previously on clozapine should be excluded from the study
- Significant medical illnesses including seizures.
- DSM-IV substance (alcohol or other drugs) abuse or dependence within the past 3 months.
- Judged clinically to be at serious suicidal risk.
- Treatment with an injectable depot neuroleptic within less than one of the patient's dosing intervals between depot neuroleptic injections prior to study entry.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT00334035
Start Date
August 1 2003
End Date
June 1 2007
Last Update
February 18 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Hong Kong, Hong Kong